Frontlight ResearchEarly access
Taking people in United StatesPhase 2
Evaluation of Uterine Fibroids by CEUS and SHAPE Pre and Post UAE
Key facts
- Who runs it
- Thomas Jefferson University
- Where
- Philadelphia, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 80 people, planned
- Started
- 27 Jan 2025
- Planned end
- 30 Sept 2026
- Type of study
- Interventional
- Treatments tested
- Perfluten
- Record updated
- 10 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Be a female diagnosed with endometrial cancer and scheduled for UAE
- Be over the age of 18 years
- If the subject is of child-bearing potential, must have a negative pregnancy test
- Be conscious and able to comply with study procedures
- Have read and signed the IRB approved consent form for participating in the study
Who cannot take part
- Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
- Patients who have undergone surgery within 24 hours prior to the study sonographic examination
- Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
- Patients with recent cerebral hemorrhage
- Patients with congenital heart defects
- Patient with a known allergy to Definity
- Females who are pregnant or nursing
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- Patients on life support or in a critical care unit
Where in United States
- Thomas Jefferson UniversityPhiladelphia, United StatesContact: Priscilla MachadoTaking people
About the trial
What the trial wants to find out
This study goals are to determine the patterns of uterine fibroid vascularity pre and post UAE using CEUS resulting in an alternative to gadolinium-enhanced MRI that is less expensive, has less contra-indications and side effects, is real time, and noninvasive helping physicians to evaluate the result of UAE procedures. Also, this study will evaluate uterine fibroid pressures using SHAPE, comparing the results with normal myometrium tissue in order to determine its characteristics and tissue differences, which we believe will lead to the development of a new biomarker for the diagnosis and treatment of uterine fibroids.
The group in the trial
- Uterine fibroidsTreatment being tested
Treatment: Perfluten
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE)
- Record updated
- 10 April 2025